1. Field of Invention
The invention of the present application relates to a therapeutic instrument for treating psoriasis, atopic dermatitis, articular rheumatism and/or cancer or preventing the progress of these diseases.
2. Description of Related Art
There has been at least carried out low dose irradiation of radial rays such as X-rays for treating psoriasis by means of radial rays (Hideo Irie, Radiation therapy respective for diseases, page 61, published by Kokuseido Shuppan K. K. (edition; Feb. 10, 1967)). However, the irradiated doses are divided into several low irradiation doses such as from 100 to 150 R (from 0.91 to 1.37 sieverts (Sv) (from 0.91 to 1.37 grays (Gy)). The total irradiation dose for several low irradiation doses becomes high such as, for example, 200 to 600 R (1.8 to 5.4 Sv (1.8 to 5.4 Gy)). Highly skilled technique is required for administering these radial rays.
For atopic dermatitis, there is no known therapy that can be carried out safely by means of low dose irradiation of radial rays.
For articular rheumatism, low dose irradiation of radial rays such as X-rays has been carried out as therapy (Hideo Irie, Radiation therapy respective for diseases, page 92, as described above). However the X-ray intensities of low dose irradiation are very high such as, for example, 80 to 100 kV for small joints and from 140 to 180 kV for large joints. Furthermore, therapy includes 5 to 10 low dose irradiations. Thus, the total irradiation dosage becomes high such as, for example, 50 to 1000 R (10 to 50 R for an acute phase, 70 to 100 R for a chronic phase) (0.46 to 9.1 Sv (0.46 to 9.1 Gy)). For therapy by means of X-ray irradiation, highly skilled technique is required as in the above-mentioned therapy for atopic dermatitis, which makes administration difficult.
For cancer therapy, X-rays are administered in a total dosage of from 3500 to 6000 rads (from 35 to 60 Sv (from 35 to 60 Gy)) (Jun Egawa, xe2x80x9cManual for cancer therapy by radial raysxe2x80x9d, page 12, Chugai Igaku Sha K. K. 1989). High skilled technique is also required for the therapy by X-ray irradiation as in the above-mentioned therapy for psoriasis, which makes administration difficult.
In the case of skin cancer, the irradiated doses by means of X-rays, 60Co or 137Sr etc. are very high such as 200 R (1.9 Sv) per one time for 20 times or more every day or every two days (Hideo Irie, Radiation therapy respective for diseases, page 65, as described above).
As to other methods, the following applies xe2x80x9cIrradiation of low dose ionized rays promotes cancer growth inside of the body. In the case of a terminal phase of cancer, an increase in a growing speed is eminent. However, the greatest effect of systemic irradiation by low dose ionized rays is to activate an anti-tumor protective mechanism in the body. As the result, growth and development of cancer are suppressed to lower the mortality by cancer.xe2x80x9d (xe2x80x9cRadioactive hormesis IIxe2x80x9d (1992, Soft Science K. K., Tokyo) (original book, T. D. LUCKEY, xe2x80x9cRADIATION HORMESISxe2x80x9d, CRC Press, Inc., Boca Raton, 1991), page 103, the second paragraph). However, systemic irradiation is essential for the method, thus practical administration is quite difficult.
Thus, there is a need for a therapy, the administration of which is substantially easier and safer, a therapy that does not require a dangerous radiation source such as, for example, an X-ray irradiation device.
The inventor of the present application has investigated and discovered a therapy by means of very low dose radiation without systemic irradiation and invented a therapeutic instrument to be used for the therapy and a preparation method therefor. That is, the invention relates to a therapeutic instrument for treating psoriasis, atopic dermatitis, articular rheumatism and/or cancer or preventing the progress thereof which is composed of a solid radiation source having a half-life within a range of from 20 to 1.41xc3x971010 years and a radioactivity corresponding to a decay rate within a range of from 10 to 370 Becquerel/g with a solid material coating the same, characterized in that the above-mentioned solid material has a radiation face for radiating radial rays emitted from the said radiation source.
Psoriasis, atopic dermatitis, articular rheumatism and cancer to be targeted by the therapy include not only in human beings but also in general mammals such as domestic animals and pet animals.
From the therapeutic instrument according to the invention, very low dose radial rays are irradiated which are within an amount that is practically harmless to the human body even though radiation is continued on the human body for long periods such as, for example, several years.
The radioactivity range of the radiation source used in the invention of the application is within a limit of radioactivity concentration for nucleic materials of such a low level that any report to the Science and Technology Agency in Japan is not necessary. That is, it is within the limit corresponding to a decay rate range of 370 Becquerel/g or less. For respective radioactivity radiated from the solid radiation source, it means that radioactivity corresponds to the decay rate within a range of from 10 to 370 Becquerel/g, preferably from 100 to 370 Becquerel/g, more preferably from 200 to 370 Becquerel/g, and most preferably from 300 to 370 Becquerel/g, or furthermore preferably from 100 to 200 Becquerel/g, 100 to 320 Becquerel/g, 200 to 320 Becquerel/g or 150 to 270 Becquerel/g. If the human body is practically undamaged by irradiation for the long period, the total dose of various radial rays may exceed 370 Becquerel/g.
The radiation source is a radioactive element of 40K, 87Rb, 113Cd, 116In, 123Te, 138La, 144Nd, 147Sm, 148Sm, 152Gd, 176Lu, 174Hf, 187Re, 188Os, 190Pt, 227Th, 232Th, 235U, 237Np or 238U or a radioactive decay series in which 232Th, 235U, 237Np or 238U is a parent.
Preferably, the radiation source is a radioactive element of 232Th, 235U, 237Np or 238U or a radioactive decay series in which any of the elements is a parent.
More preferably, the radiation source is a radioactive element of 232Th or 235U or a radioactive decay series in which any of the elements is a parent.
Still more preferably, the radiation source is a radioactive element of 232Th or a radioactive decay series in which the element is a parent.
The radiation source can maintain quite low dose radioactivity stably for the long period, wherein a half-life is within a range of from 20 to 1.41xc3x971010 years.
It is preferable that the radiation source is a natural ore, preferably a natural ore containing a radioactive element of 232Th, 235U, 237Np or 238U or a radioactive decay series in which any of the elements is parent, more preferably a radioactive element of 232Th or 238U or a radioactive decay series in which any of the elements is parent, and more preferably a radioactive element of 232Th or a radioactive decay series in which the element is parent.
Preferably, the radiation source is monazite containing from 3 to 15% (calculated as 232ThO2) of a radioactive decay series in which 232Th is parent.
The solid material used in the therapeutic instrument according to the invention may be any solid material which can prevent scattering of the radiation source by coating the radiation source with the solid material and which can radiate xcex3-ray with or without xcex2-ray from the surface of the solid material in the therapeutic instrument according to the invention.
Methods of coating the radiation source with the solid material include coating the radiation source, which is generally in the form of gravel, granules or preferably powders, by placing them in a flexible or solid vessel such as a bag, a can and a box, and a method to coat the radiation source bodies or particles or body groups or particle groups in the form of gravel, granules or preferably powders with molten solid material individually and cooling them.
When using a bag to coat the radiation source, the bag is, if desired, quilted by connecting the parts of the upper and lower faces with threads or strings to assure that powders of the solid radiation source are distributed evenly. The bag becomes an approximate plate form with a thickness of from 5 to 20 mm excepting quilted parts when filled with the powders of the solid radiation source.
The vessel such as a bag, a can and a box composed of solid material for receiving and coating the radiation source is made of a material that does not irritate the skin, such as, for example, mineral ores and metal compounds such as metal oxides, for example glass or fibers thereof; metals or metal fibers: synthetic organic materials such as plastics or fibers thereof; cotton, silk, paper, wool, leather, natural rubber and/or synthetic rubber. The form thereof is a soft and flexible textile, nonwoven fabric, membrane or plate. The membrane and the plate may be porous.
Examples of plastics that may be used include: polyalkylene plastics such as polyethylene, polypropylene, polybutylene, polyisobutylene and polyacryls; natural rubber; polyester type plastics such as PET; silicone resins; and polyamide resins such as nylon. It is possible to use reinforced plastics in order that the vessel is not destroyed easily by cutting, abrasion or tearing.
Furthermore, the solid material may be, if desired, quilted or sectioned in order for powders of the solid radiation source to be evenly distributed. The vessel becomes an approximate plate form with a thickness of from 5 to 20 mm except for quilted parts or sectioned parts when filled with the powders of the solid radiation source. The solid material may be a soft and flexible textile, membrane or plate made of metal.
Metal, as the solid material, is preferably in the form of a plate having a thickness of from 0.1 to 3 mm. It is preferably an anti-corrosive metal plate, a metallic plate with a preserved surface or a stainless steel plate.
Preferably, the metallic plate is an anodized aluminum plate, a tin plate, a zinc-plated iron plate, an enamel plate, a plastic-coated iron plate, a stainless steel plate or a lead plate.
Preferably, the solid material is a soft and flexible textile, nonwoven fabric or membrane made of cotton, silk, paper, wool, leather, natural rubber and/or synthetic rubber.
Thus, by coating the radiation source with the solid material, scattering of the radiation source can be prevented and xcex3-ray with or without xcex2-ray can be radiated from the surface of the solid material.
The thickness of the coating parts in the vessel is generally from about 0.1 to 3 mm. The thickness may be deviated from that range according to the desired strength (abrasion resistance, cutting resistance, tear resistance). And, any thickness may be used if the major part of xcex3-ray can be transmitted therethrough.
A whole or a part of the outer surface of the solid material which coats the radiation source may also be coated with other material for filtering a part of xcex3-ray, except for the radiation face which radiates radial rays of mainly xcex3-ray toward skins to be irradiated.
The radiation face for radiating radial rays includes a part or, for rare cases, a whole of the surface of the solid material which is coated with the radiation source. It is preferably a surface of an easily deformable flexible solid body such as a bag in order to arrange the surface to fit it on the skin surface.
The distance between the radiation face for radiating very low dose radial rays and the irradiated part affected with the above-mentioned diseases such as psoriasis may be any one provided that the radial rays can be utilized practically and efficiently. Generally, the radiation face for radiating radial rays may be separated from the affected skin surface for a distance of from 0 to 50 mm in a direction perpendicular to the skin surface.
If necessary, direct contact between the radiation face of the instrument and the skin may be avoided by positioning a sheet or fabric (which may be hygroscopic for absorption of sweat) made of a radioactively transparent material which seldom absorbs xcex3-rays between the radiation face of the instrument and the skin.
The shape of the radiation face may be a flat face, a bent face or a corrugated face or mixture thereof. It may be preferably any one among the above-mentioned shapes provided that very low dose radial rays can be utilized efficiently and that it can minimize radiation on unaffected parts.
The radiation face may be continuous or discontinuous.
In the case of continuous radiation face, it may be one piece of a flat face, a corrugated face such as a washing plate face, a face consisting of multiple bent faces or a roughened face. It may also be a surface of a bag made of textile, nonwoven fabric or fabric.
If the radiation face of the solid material is a discontinuous flat face, multiple radiation faces are connected by joints in order to make the multiple flat radiation faces fitted with the surface form of the skin on which the instrument is worn. For example, the face may be bent freely according to the surface form of the affected skin part on which the instrument is worn. The joints used in that case may be strings, chains, fabrics, textile or wires to be connected with respective flat constitutional parts.
In order to collect natural ores containing the radiation source such as mineral radioactive isotopes near the radiation face which radiates radial rays, the following method may be carried out. That is, the solid material is molten, and powders of the above-mentioned natural ore are blended into the molten material. The blend is allowed to leave as such with maintaining the temperature in the vessel having the flat bottom inner face, during which the powders are deposited by utilizing the gravity difference between of the solid material and the powders. Thereby, powders of the mineral ore are collected at the bottom of the vessel. After collection, the molten material is cooled to solidify and removed from the vessel. The part contacted with the inner bottom face of the vessel is used as the radiation face of the therapeutic instrument according to the invention.
To this end, it is necessary that the solid material is solid at the normal temperature and that the material has enough low viscosity to deposit particles and/or powders of the natural ore containing natural radioactive isotopes and lower specific gravity than that of the above-mentioned natural ore.
Examples of preferable solid materials having such properties include: inorganic oxides having lower specific gravities than natural ores such as glass, Pyrex, or silicon oxides such as crystals, ester type and/or paraffin type waxes.
Ester type waxes include plant waxes such as Caunauba wax, Japan wax and sugar wax, as well as animal waxes such as beeswax, insect wax, whale wax and wool wax.
Hydrocarbon waxes may include paraffin waxes and microcrystalline waxes. Additionally, synthetic waxes may include carbon wax and polyethylene wax.
It is essential that these waxes effect no reactions such as, for example, skin burns, allergies, eruptions or absorptions when in contact with the skin of human beings or mammal.
Preferable waxes may include Japan wax and beeswax.
The invention of the present application also relates to a method for preparing the above-mentioned therapeutic instrument or a part thereof, that is, a method for preparing a therapeutic instrument for treating or relieving psoriasis, atopic dermatitis, articular rheumatism and/or cancer or preventing the progress of these diseases by mixing a natural ore containing natural radioactive isotopes with molten ester type and/or paraffin type wax uniformly, then introducing the obtained mixture in a casting type mold to deposit the natural ore at the bottom of the mold while maintaining the wax in the molten state, and then solidifying the ore in deposited state.
Part of the therapeutic instrument obtained by the above-mentioned preparation method may be in the form of a flat plate or a bent plate formed into a triangle, square, rectangle, right hexagon, circle, oval or polygon with or without irregularity.
The therapeutic instrument according to the invention can be prepared by connecting multiple parts of the therapeutic instrument with each other in such a way as to form either a flat face or a bent face, by which the skin to be fitted with the therapeutic instrument, according to the invention, can be covered with these multiple radiation faces.
As described above, irradiation energy of radial rays radiated from the prepared therapeutic instrument according to the invention is quite low.
For the case of a cotton bag in which powders (from 30 to 50 mesh) of monazite having a value of 220 Bq/g supposed from xcex3-ray determination and 350 Bq/g supposed from xcex2-ray determination, the dose of irradiated radial rays is 20 xcexcSv/lr in the central surface part of the bag for the thickness of about 30 mm and the monazite amount of 700 g. The therapeutic instrument having such thickness is used mostly for skin diseases such as psoriasis, atopic dermatitis and skin cancer.
The dose of irradiated radial rays is 50 xcexcSv/hr in the central surface part of the bag for the case in which thickness of monazite powders (from 30 to 50 mesh) is about 50 mm and the monazite amount is 5 kg. The therapeutic instrument having such thickness is used mostly for treating affected parts deep inside the body (e.g., articular rheumatism, respiratory cancer and digestive cancer) or preventing the recurrence thereof.
Irradiation energy varies depending on the radiation source used as well as the thickness and the width of the radiation source. For example, when the therapeutic instrument is a bag containing the radiation source, it is relatively low at ends of the radiation face and relatively high at the central part of the radiation face, and there is a tendency of increase in the irradiation energy at the central part with increase in the thickness of the bag or the area of the radiation face.
For the case of using the above-mentioned powders of monazite in a cotton bag (the case in which the solid material is a cotton fabric), the thickness may be within the range of from about 5 mm to 100 mm, preferably from 5 to 50 mm. Irradiation energy at the central part of the radiation face is within the range of generally from 10 to 100 xcexcSv/hr, preferably from 30 to 50 xcexcSv/hr. However, the range of irradiation energy may be deviated from the indicated range to a higher one depending on a continuous or discontinuous irradiation period provided that it is within a range harmless to the human body practically.
When treating cancer which is a disease occurring inside of the body or preventing the progress thereof, the therapeutic instrument according to the invention may be embedded in a part of the body that is nearest to the affected part.
For such case, the solid radiation source should be coated with the solid material or evenly dispersed in the solid material. The form thereof may be of any type.
The solid radiation source coated with the solid material may be positioned in multiple forms such as, for example, a particulate one at the site to be treated or relieved.
The therapeutic instrument according to the invention may be arranged in the part that is nearest to the affected site, such as, for example, outside or inside of a tubular cavity such as the oral cavity, the gullet and the intestine, the inside of the vagina or the outside of a blood vessel, the breast cavity and the abdominal cavity, instead of the above-mentioned embedding.
The solid material to be embedded is a non-toxic material that is not easily influenced by endometabolism such as silicone resins or high molecular chemical materials. Furthermore, it is possible to fix the radiation source in artificial blood vessels (grafts) prepared from these materials.
Progress of the therapy is judged by observation of skin surface for the cases of psoriasis and atopic dermatitis.
Within the period for irradiating very low dose radial rays from the radiation face of the therapeutic instrument according to the invention, the condition of psoriasis or atopic dermatitis gradually disappears.
The period for positioning the radiation face of the therapeutic instrument on the entire surface of the affected skin or a part thereof may be continuous or discontinuous.
Generally, the radiation face of the therapeutic instrument is positioned on the surface of the affected skin for from 6 to 16 hours per day.
Generally, days required for recovery of psoriasis or atopic dermatitis are about 3 months for the case that the therapeutic instrument is positioned on the surface of the affected skin for from 6 to 16 hours per day. However, the period varies depending on the condition of psoriasis or atopic dermatitis.
The irradiated dose by the therapeutic instrument according to the invention for such a case is 20 (xcexcSv/hr)xc3x9716 hrxc3x97365 day=116,800 xcexcSv/hr=about 120 millisievert/y, calculated from treatments of 16 hours per day for 1 year. The irradiated dose is quite low compared with the irradiated dose of X-rays for the conventional therapeutic case of psoriasis, that is from 1.8 to 5.4 Sv. The low dose can also apply for skin cancer.
When the shape of the affected skin is not flat, parts of a therapeutic instrument having a flat or bent radiation face as described above are connected with joints, if necessary, to form the radiation face suitably, i.e., according to the shape of the skin surface. It can be then positioned on the surface of the part affected with psoriasis for treating. Furthermore, the radiation face of the soft and flexible bag can be positioned on the surface of the part affected with psoriasis or atopic dermatitis.
Therefore, the invention of the present application relates also to a method for treating or relieving psoriasis or atopic dermatitis by radioactively applying the radiation face of very low dose according to the invention on a part or a whole of the skin affected with psoriasis or atopic dermatitis by means of radial rays.
From the results for the therapeutic instrument used until now, there are found some cases in which light recurrence of psoriasis or dermatitis after a certain period even after an apparent full recovery. For such cases, it is preferable to irradiate by means of the therapeutic instrument for psoriasis according to the invention for from 1 hour to 16 hours, preferably from about 1 hour or 6 hours to 16 hours, only while the patient is asleep and to monitor the symptoms due to psoriasis or atopic dermatitis periodically for the residual life of the patient.
Since the irradiated dose by means of the therapeutic instrument for psoriasis according to the invention is within a very low range that is substantially harmless to the human body, there is supposedly no disorder caused by irradiation of radial rays with the therapeutic instrument according to the invention. Even for the cases wherein a very light damage such as a partial defect on gene sequence occurs, irradiation is discontinuously applied and there is a non-irradiated period of several hours, during which the defect in the gene sequence can be recovered enough. Therefore, even if the therapeutic instrument according to the invention is used for a long period, it is not expected to cause gene disorder such as skin disease and marrow functional disorder. Practically, no condition corresponding to such gene disorders has been observed by the inventor.
For the therapy of psoriasis and atopic dermatitis by means of the therapeutic instrument according to the invention, it is considered in one aspect that very low dose radial rays radiated from the radiation face of the above-mentioned therapeutic instrument can expel cells (lymphocytes) relating to the immune system and the allergy system collected on the above-mentioned affected skin, thereby the above-mentioned diseases are eliminated.
For treating the skin diseases sited topically such as psoriasis and atopic dermatitis by means of the therapeutic instrument according to the invention, an amount of the radiation source can be decreased less than that for the cases of treating diseases at deep parts such as articular rheumatism and cancer per an unit area of skins on which the therapeutic instrument is fitted, for example half the amount.
For preventing the progress of articular rheumatism and cancers, for instance cancers in the liver, the spleen, the peritoneum, the mediastinum organ, the lung, the pleura and the thorax present in a deep part of the body or relieving or treating these diseases, similarly to the skin diseases such as psoriasis and atopic dermatitis, the therapeutic instrument according to the invention may be fitted on or near the skin surface nearest to the affected parts. For such cases, it is not systemically fitted and at most only an amount enough to cover the affected parts is used. Since the affected parts are deep inside the body and somewhat removed from the radiation source, from 1 to 3 times the radiation source for the case of treating skin diseases, and optionally 5 times of the radiation source may be used.
The fitting period of the therapeutic instrument according to the invention for targeting articular rheumatism or cancer is from 8 hours to 24 hours every day.
If 100 (xcexcSv/hr), which dose is 5 times of the case for skin diseases, is irradiated every day for 24 hours, the total dose for 1 year becomes
100(xcexcSv/hr)xc3x9724 hrxc3x97365 day 0.876(Sv).
The irradiated dose is quite low compared with the conventional X-ray irradiated dose for the case of chronic articular rheumatism which is at least 3.15 Sv (3.15 Gy). Similarly, it is a very low dose compared with the irradiated dose for relieving or treating cancer present deeply inside of the body, which is at least from 30 to 60 Sv (from 30 to 60 Gy). And, the irradiating period by means of the therapeutic instrument according to the invention is long such as 1 year, but it is different from the irradiation period for X-ray divided irradiation. Thus, irradiation energy per unit time is quite low.
Additionally, any erythema is not recognized by the therapeutic instrument according to the invention after 2 years irradiation.